Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Reference Treatment: 1 x amlodipine and 1 x losartan administered in · 1 trial · 1 indication
Comparison of Cmax and Clast after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)
Comparison of Tmax after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)
Comparison of AUCt, AUCinf and %AUCex after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)
Comparison of t½ after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)
| Arm | Type | Description |
|---|---|---|
| Treatment Period 1 | OTHER | 1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state |
| Treatment Period 2 | OTHER | 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state |
| Treatment Period 3 | OTHER | 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state |
| Name | Type | Description |
|---|---|---|
| Reference Treatment: 1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state | DRUG | 1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state |
| Fixed Dose Combination 1: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state | DRUG | 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state |
| Fixed Dose Combination 2: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state | DRUG | 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state |
Inclusion Criteria: * Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Alanine transaminase (ALT), alkaline phosphatase and bilirubin ≤ 1.5 x upper limit of normal (ULN; isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated an...
Top 7 of 14 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 4 | PHASE3 | Orforglipron, LY3971297 |
| Alnylam Pharmaceuticals, Inc | ALNY | 2 | PHASE3 | Zilebesiran, ALN-AGT01 RVR |
| Mineralys Therapeutics, Inc. | MLYS | 1 | PHASE3 | lorundrostat |
| United Therapeutics Corporation | UTHR | 1 | PHASE3 | Ralinepag |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | QCZ484 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | iloperidone |
| Opus Genetics, Inc. | IRD | 1 | PHASE1 | OPGx-BEST1 |
It is a fixed dose combination reference treatment containing 5 mg amlodipine and 100 mg losartan, studied in healthy adult volunteers as a comparator for hypertension-related bioavailability testing. The combination pairs amlodipine with losartan in a single tablet formulation. The trial enrolled 23 healthy participants in Australia.
GSK plc, which trades under the ticker GSK, is the developer of this amlodipine and losartan fixed dose combination reference treatment. The company sponsored the Phase 1 bioavailability study of the combination tablet. The work sits within the cardiovascular therapeutic area and relates to hypertension.
It is in Phase 1 development. The single registered trial, NCT01648231, is a Phase 1 crossover bioavailability study that has been completed. It is an investigational fixed dose combination and is not described as approved. The study enrolled 23 healthy volunteers and was conducted in Australia.
NCT01648231 is the registered trial. Titled a crossover study to evaluate the comparative bioavailability of two fixed dose combination tablet formulations of amlodipine and losartan in healthy volunteers, it was a completed Phase 1 study with 23 enrolled participants, randomized and controlled, conducted in Australia with healthy volunteers aged 18 years and older.
Yes. The reference treatment is also known as 1 x 5 mg amlodipine tablet and 1 x 100 mg losartan tablet administered in the fasted state, and as 1 x amlodipine and 1 x losartan administered in the fasted state. These names describe the same fixed dose combination reference arm used in the bioavailability study.